pentasa

Generic: mesalamine

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pentasa
Generic Name mesalamine
Labeler takeda pharmaceuticals america, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

mesalamine 500 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-191
Product ID 54092-191_42661699-8fcc-40da-a05d-91906f9973e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020049
Listing Expiration 2026-12-31
Marketing Start 2004-07-08

Pharmacologic Class

Established (EPC)
aminosalicylate [epc]
Chemical Structure
aminosalicylic acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54092191
Hyphenated Format 54092-191

Supplemental Identifiers

RxCUI
206791 314092 476362 580286
UPC
0354092191123 0354092189816
UNII
4Q81I59GXC
NUI
N0000175781 M0000971

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pentasa (source: ndc)
Generic Name mesalamine (source: ndc)
Application Number NDA020049 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 120 CAPSULE in 1 BOTTLE (54092-191-12)
source: ndc

Packages (1)

54092-191-12 120 CAPSULE in 1 BOTTLE (54092-191-12)

Ingredients (1)

mesalamine (500 mg/1)

Linked Drug Pages (1)

Pentasa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42661699-8fcc-40da-a05d-91906f9973e8", "openfda": {"nui": ["N0000175781", "M0000971"], "upc": ["0354092191123", "0354092189816"], "unii": ["4Q81I59GXC"], "rxcui": ["206791", "314092", "476362", "580286"], "spl_set_id": ["e39d9a3d-5d3a-4bb6-aab1-fdbb2a598606"], "pharm_class_cs": ["Aminosalicylic Acids [CS]"], "pharm_class_epc": ["Aminosalicylate [EPC]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (54092-191-12)", "package_ndc": "54092-191-12", "marketing_start_date": "20040708"}], "brand_name": "Pentasa", "product_id": "54092-191_42661699-8fcc-40da-a05d-91906f9973e8", "dosage_form": "CAPSULE", "pharm_class": ["Aminosalicylate [EPC]", "Aminosalicylic Acids [CS]"], "product_ndc": "54092-191", "generic_name": "mesalamine", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pentasa", "active_ingredients": [{"name": "MESALAMINE", "strength": "500 mg/1"}], "application_number": "NDA020049", "marketing_category": "NDA", "marketing_start_date": "20040708", "listing_expiration_date": "20261231"}